EFFICACY AND TOLERABILITY OF (R)ESTRADERM-MX, A NEW ESTRADIOL MATRIX PATCH

Objectives: To assess the efficacy and tolerability of a new matrix pa tch delivering 0.05 mg estradiol per day (Estraderm MX 50) in postmeno pausal women with moderate to severe postmenopausal symptoms. Methods: A multicenter, double-blind, randomized, between-patient, placebo con trolled trial in 109 postmenopausal women was carried out. Patches wer e applied twice weekly for 12 weeks. Patients were assessed at 4, 8 an d 12 weeks of treatment. The primary efficacy variable was change from baseline in mean number of moderate to severe hot flushes (including night sweats) per 24 h during the last 2 weeks of treatment. Other var iables included Kupperman Index, local and systemic tolerability. Plas ma concentrations of estradiol (E2), estrone (El) and estrone sulfate (E1S) were determined before and after treatment. Results: Estraderm M X was significantly superior to placebo (P < 0.001) in reducing mean n umber of moderate to severe hot flushes (including night sweats) per 2 4 h after 4, 8 and 12 weeks of treatment. The estimate of treatment gr oup differences after 12 weeks was 4.2 hot flushes (95% confidence int erval: 2.6-5.5). Estraderm MX also significantly reduced Kupperman Ind ex at all time points compared to placebo (P ( 0.001). Estraderm MX in duced increases in mean E2, E1 and E1S plasma levels as expected (E2: baseline 2.7 pg/ml, 12 weeks 38.9 pg/ml; El: baseline 18.8 pg/ml, 12 w eeks 41.6 pg/ml; E1S: baseline 235.6 pg/ml, 12 weeks 765.1 pg/ml). Ove rall rates of adverse experiences were similar for Estraderm MX and pl acebo. The number of patients reporting skin irritation was low and si milar in both groups. Conclusions: Estraderm MX 50, a new matrix patch , offers an effective and well tolerated dosage form for transdermal d elivery of 0.05 mg E2 per day. (C) 1997 Elsevier Science Ltd.